FDA Product Code
FDA Product Code GEI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4400
510(k) Clearances — 2,319 records · page 17 of 24
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K971711 | SOMNUS MODEL 215 ELECTROSURGICAL GENERATOR | Somnus Medical Technologies, Inc. | 1997-06-24 | Traditional | PDF ↗ |
| K972072 | SURGITRON MODEL FFPF-EMC | Ellman Intl., Inc. | 1997-06-19 | Traditional | PDF ↗ |
| K970809 | BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL | Somnus Medical Technologies, Inc. | 1997-06-18 | Traditional | PDF ↗ |
| K972161 | BOVIE MODEL X15 | Maxxim Medical | 1997-06-18 | Traditional | PDF ↗ |
| K971805 | ELECTROSURGICAL TIP CLEANER, TIP CLEANING PAD, LECTROBRASIVE TIP CLEANER, ELECTROSURGICAL TIP CLEANER, ELECTRODE TIP CLE | Aaron Medical Industries | 1997-06-13 | Traditional | PDF ↗ |
| K971674 | VALLEYLAB SINGLE USE SOLID LAPAROSCOPIC ELEC. SPATULA (STRAIGHT & CURVED) J&L HOOK, BALL CONMED SOLID SHAFT ELECTRODE ST | Aaron Medical Industries | 1997-06-11 | Traditional | PDF ↗ |
| K970797 | OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES | Olympus America, Inc. | 1997-05-28 | Traditional | PDF ↗ |
| K970993 | DEROYAL INDUSTRIES, INC. DISPOSABLE BIPOLAR ELECTROSURGICAL CABLE | Deroyal Industries, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K971341 | KIRWAN MODEL 28 1000 BIPOLAR COAGULATOR | Kirwan Surgical Products, Inc. | 1997-05-22 | Traditional | PDF ↗ |
| K964329 | UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) | Richard Wolf Medical Instruments Corp. | 1997-05-21 | Traditional | PDF ↗ |
| K970987 | ELECTROSURGICAL ELECTRODE | Fusion Medical Technologies, Inc. | 1997-05-05 | Traditional | PDF ↗ |
| K965199 | TUNA 5 CATHETER | Vidamed, Inc. | 1997-04-30 | Traditional | PDF ↗ |
| K970493 | HYFRECATOR 2000 | Aspen Labs | 1997-04-30 | Traditional | PDF ↗ |
| K971092 | QA-ES | Smith | 1997-04-23 | Traditional | PDF ↗ |
| K971040 | CABLE HOLDER, SUCTION TUBE HOLDER | Contour Fabricators, Inc. | 1997-04-16 | Traditional | PDF ↗ |
| K963646 | STRYKER STRYKEFLOW SUCTION IRRIGATOR GRAVITY FLOW | Stryker Endoscopy | 1997-04-16 | Traditional | PDF ↗ |
| K964849 | ARTHROCARE DERMATOLOGIC ELECTROSURGERY SYSTEM | Arthrocare Corp. | 1997-04-14 | Traditional | PDF ↗ |
| K970184 | OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES | Olympus America, Inc. | 1997-04-11 | Traditional | PDF ↗ |
| K970576 | SOMNUS MODEL 615 ELECTROSURGICAL GENERATOR(MODEL 615) | Somnus Medical Technologies, Inc. | 1997-04-09 | Traditional | PDF ↗ |
| K970826 | SELECTA-TIP LAPAROSCOPIC SCISSORS | Microline Pentax, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K970140 | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH | Valleylab, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K970130 | HYDROCOOL DUAL CONDUCTOR POLYMER GEL (30101-001/CORDED DISPERSIVE ELECTRODE-SENSING | Medtrex, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K970541 | AESCULAP MODULAR MONOPOLAR ELECTRODES | Aesculap, Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K964636 | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM | Valleylab, Inc. | 1997-03-11 | Traditional | PDF ↗ |
| K965241 | BIPOLAR SUCTION COAGULATOR | Kirwan Surgical Products, Inc. | 1997-02-28 | Traditional | PDF ↗ |
| K964736 | BERGEN 610 BIPOLAR COAGULATOR | Bergen Mfg. | 1997-02-27 | Traditional | PDF ↗ |
| K970039 | ENCORE ELECTROSURGICAL HANDCONTROL PENCIL (35001-001) | Medtrex, Inc. | 1997-02-26 | Traditional | PDF ↗ |
| K965243 | ENDOCARE ELECTROSURGICAL ELECTRODE | Endocare, Inc. | 1997-02-25 | Traditional | PDF ↗ |
| K970066 | UNIMED COATED LAPAROSCOPIC/ARTHROSCOPY/SUCTION-IRRIGATION ELECTRODE | Unimed Surgical Products, Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K965086 | CYGNUS ELECTROSURGICAL TIP CLEANER | Madison Polymeric Engineering | 1997-02-14 | Traditional | PDF ↗ |
| K965007 | ORATEC INTERVENTIOUNS ELECTROSURGICAL PROBES | Oratec Interventions, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K963765 | STRYKER STRYKEFLOW ELECTROCAUTERY PROBES | Stryker Endoscopy | 1997-01-31 | Traditional | PDF ↗ |
| K965061 | VIDAMED MODEDL 7600 RF GENERATOR | Vidamed, Inc. | 1997-01-28 | Traditional | PDF ↗ |
| K965054 | PENCIL | Megadyne Medical Products, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K963930 | CTS MIDCAB/SVH BIPOLAR SCISSORS | Cardiothoracic Systems, Inc. | 1997-01-16 | Traditional | PDF ↗ |
| K964143 | MINI-SYMM BIPOLAR COAGULATOR | Valley Forge Scientific Corp. | 1997-01-09 | Traditional | PDF ↗ |
| K964602 | DAVIS BAYONET ELECTRODES | Valleylab, Inc. | 1997-01-09 | Traditional | PDF ↗ |
| K963985 | UM-D3000/UM-D4000 | J.J. Consulting Services, Inc. | 1996-12-27 | Traditional | PDF ↗ |
| K964621 | A & E MEDICAL ELECTROCAUTERY SUCTION TUBE WITH FINGER TIP ACTIVATOR BUTTON | Alto Development Corp. | 1996-12-20 | Traditional | PDF ↗ |
| K963884 | SOMNUS DISPOSABLE MULTIPLE ELECTRODE COAGULATING PROBE MODEL 350 | Somnus Medical Technologies, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K964071 | ORATEC INTERVENTIONS MODEL ORA 50 ELECTROTHERMAL GENERATOR | Oratec Interventions, Inc. | 1996-12-12 | Traditional | PDF ↗ |
| K964175 | VALLEYLAB E2750 LAPAROSCOPIC HANDSET, VALLEYLAB E2770 SERIES ELECTRODES | Valleylab, Inc. | 1996-12-05 | Traditional | PDF ↗ |
| K963189 | ERBE APC 300 ARGON PLASMA COAGULATOR AND ACCESSORIES - ARGON PLASMA COAGULATOR AND ACCESSORIES | Erbe USA, Inc. | 1996-11-26 | Traditional | PDF ↗ |
| K963783 | MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE | ETHICON, Inc. | 1996-11-25 | Traditional | PDF ↗ |
| K961334 | HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE | Heartport, Inc. | 1996-11-15 | Traditional | PDF ↗ |
| K962593 | ELECTROSURGICAL PROBES & DEVICES | Ximed/Prosure/Injectx | 1996-11-12 | Traditional | PDF ↗ |
| K962690 | E2590 - B, ARGON ACCESSORY WITH BLADE ELECTRODE AND E2590 - N, ARGON ACCESSORY WITH NEEDLE ELECTRODE | Valleylab, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K963901 | ELECTROSURGICAL PROBE | Smith & Nephew Endoscopy, Inc. | 1996-11-04 | Traditional | PDF ↗ |
| K963772 | SOMNUS MODEL 225 ELECTRO SURGICAL GENERATOR (MODEL 225) | Somnus Medical Technologies, Inc. | 1996-10-23 | Traditional | PDF ↗ |
| K963338 | UNIMED SUCTION-IRRIGATION ELECTRODE AND SLIDING SHEATH | Unimed Surgical Products, Inc. | 1996-10-21 | Traditional | PDF ↗ |
| K963180 | VIDAMED RF GENERATOR DATA RECORDER | Vidamed, Inc. | 1996-10-10 | Traditional | PDF ↗ |
| K961647 | DEROYAL INDUSTRIES, INC. ELECTROSURGICAL CAUTERY PENCIL | Deroyal Industries, Inc. | 1996-10-08 | Traditional | PDF ↗ |
| K963123 | ARTHROCARE ARTHROSCOPIC ELETROSURGERY SYSTEM (MODEL 980) | Arthrocare Corp. | 1996-10-08 | Traditional | PDF ↗ |
| K960918 | VIDAMED TUNA (TRANSURETHRAL NEEDLE ABLATION) SYSTEM | Vidamed, Inc. | 1996-10-08 | Traditional | PDF ↗ |
| K963499 | MIRROR FINISH BIPOLAR FORCEPS | Johnson & Johnson Professionals, Inc. | 1996-10-08 | Traditional | PDF ↗ |
| K961771 | AUTO SUTURE SURGIWAND | United States Surgical, A Division of Tyco Healthc | 1996-09-25 | Traditional | PDF ↗ |
| K962692 | ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBE | Zomed Intl. | 1996-09-19 | Traditional | PDF ↗ |
| K963157 | ORATEC INTERVENTIONS MODEL TAC-S MONOPOLAR CAUTERY PROBE (MODIFY) | Oratec Interventions, Inc. | 1996-09-18 | Traditional | PDF ↗ |
| K963088 | SHEATH, ELECTROSURGICAL PENCIL | Aspen Laboratories, Inc. | 1996-09-13 | Traditional | PDF ↗ |
| K962935 | UNIMED COATED NEEDLE ELECTRODE/COATED BLADE ELECTRODE/COATED BALL ELECTRODE | Unimed Surgical Products, Inc. | 1996-09-03 | Traditional | PDF ↗ |
| K962044 | VALLEYLAB COATED ELECTRODES | Valleylab, Inc. | 1996-08-30 | Traditional | PDF ↗ |
| K962678 | BIPOLAR PENCIL COAGULATOR | Kirwan Surgical Products, Inc. | 1996-08-14 | Traditional | PDF ↗ |
| K962119 | RE-NEW LAPAROSCOPIC INSTRUMENTS | Microline Pentax, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K955792 | WILO SERIES SECUR, AUTOMATIC TROCAR SET, TROCAR, CONICAL, TRIANGULAR GROUND, SAFETY W/OUT LOCK, SET OF SUCTION - IRRIGA0 | Wilo Medizintechnik Lothar Wilberg GmbH | 1996-07-26 | Traditional | PDF ↗ |
| K961264 | ENDOPATH EZ-RF LINEAR CUTTER AND COAGULATION | Ethicon Endo-Surgery, Inc. | 1996-07-19 | Traditional | PDF ↗ |
| K961505 | BEND-A-BEAM HAND CONTROL MALLEABLE ABC HANDPIECE | Conmedcorp | 1996-07-18 | Traditional | PDF ↗ |
| K955834 | SYSTEM 6500 ABC ELECTROSURGICAL UNIT | Aspen Laboratories, Inc. | 1996-07-11 | Traditional | PDF ↗ |
| K961133 | SOMNUS MEDICAL TECH. MALLEABLE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1996-07-10 | Traditional | PDF ↗ |
| K961197 | SELECTONE UNIVERSAL PLUS MUNRO LAPAROSCOPIC LOOP ELECTRODE MODEL 60-5276 SERIES | Conmedcorp | 1996-06-21 | Traditional | PDF ↗ |
| K962030 | KARL STORZ REMORGIDA FORCEPS | KARL STORZ Endoscopy-America, Inc. | 1996-06-14 | Traditional | PDF ↗ |
| K961812 | ELECTROSURGICAL AND ARTHROSCOPY ACCESSORY ELECTRODES | Conmedcorp | 1996-06-13 | Traditional | PDF ↗ |
| K961097 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Debusk Knitting Mills, Div. Deroyal Industries | 1996-06-03 | Traditional | PDF ↗ |
| K961616 | TELESCOPING PENEVAC (MODIFICATION) | I.C Medical, Inc. | 1996-05-28 | Traditional | PDF ↗ |
| K961132 | SOMNUS MEDICAL TECH SOFT TISSUE COAGULATING ELECTRODE | Somnus Medical Technologies, Inc. | 1996-05-22 | Traditional | PDF ↗ |
| K961087 | DEROYAL SURGICAL (SURGIMATE) PENCIL ADAPTERS | Debusk Knitting Mills, Div. Deroyal Industries | 1996-05-16 | Traditional | PDF ↗ |
| K961473 | HM-88011 SOLID STATE ELECTR SURGICAL UNIT | Hill-Med, Inc. | 1996-05-07 | Traditional | PDF ↗ |
| K960695 | MODEL 200C ELECTROSURGICAL PROBE | Zomed Intl. | 1996-04-30 | Traditional | PDF ↗ |
| K954171 | ARCO-MBC, ARCO MC | Holl Meditronics, Inc. | 1996-04-30 | Traditional | PDF ↗ |
| K960694 | ZOMED 30F ELECTROSURGICAL PROBE | Zomed Intl. | 1996-04-30 | Traditional | PDF ↗ |
| K955166 | PENEVAC SI. | I.C Medical, Inc. | 1996-04-11 | Traditional | PDF ↗ |
| K955020 | PENEVAC ABC HANDPIECE | I.C Medical, Inc. | 1996-04-09 | Traditional | PDF ↗ |
| K955144 | RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000 | Radiotherapeutics Corp. | 1996-04-07 | Traditional | PDF ↗ |
| K955352 | SUCTION CAUTERY PROBE | Mectra Labs, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K960476 | ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE | ETHICON, Inc. | 1996-04-05 | Traditional | PDF ↗ |
| K960255 | CERAMIC BLADE ELECTRODE | Utah Medical Products, Inc. | 1996-03-27 | Traditional | PDF ↗ |
| K960808 | CONMED SELECT ONE LAPAROSCOPY ELECTRODE | Conmedcorp | 1996-03-21 | Traditional | PDF ↗ |
| K960569 | DISPOSABLE PATIENT RETURN ELECTRODE | Erbe USA, Inc. | 1996-03-11 | Traditional | PDF ↗ |
| K943014 | BALLOON ELECTROSURGICAL PROBES AND DEVICES | Ximed Medical Systems | 1996-03-11 | Traditional | PDF ↗ |
| K960009 | STORZ S2050 SERIES BIPOLAR FORCEPS | Storz Instrument Co. | 1996-03-06 | Traditional | PDF ↗ |
| K960554 | DETACHATIP THORACOSCOPIC SCISSORS | Microsurge, Inc. | 1996-03-05 | Traditional | PDF ↗ |
| K955764 | VALLEY FORGE BIPLOAR LOOP | Valley Forge Scientific Corp. | 1996-03-01 | Traditional | PDF ↗ |
| K960455 | BIPOLAR SUCTION COAGULATOR | Kirwan Surgical Products, Inc. | 1996-02-27 | Traditional | PDF ↗ |
| K960296 | 4000 ETM | Aspen Laboratories, Inc. | 1996-02-20 | Traditional | PDF ↗ |
| K955623 | OLYMPUS BIPOLAR FORCEPS | Olympus America, Inc. | 1996-02-13 | Traditional | PDF ↗ |
| K955167 | SURGITRON | Ellman Intl., Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K955681 | AARON 800 HIGH FREQUENCY DESICCATOR/HANDPIECE | Geiger Instrument Co., Inc. | 1996-02-08 | Traditional | PDF ↗ |
| K955836 | VALLEYLAB COATED ELECTRODES | Valleylab, Inc. | 1996-02-01 | Traditional | PDF ↗ |
| K955261 | NEUTRALECT ADULT STANDARD, RETURN (REM) & PAEDIATRIC ELECTROSURGERY PLATE (MODIFICATION) | Msb , Ltd. | 1996-01-30 | Traditional | PDF ↗ |
| K955163 | DISSECTION PROBE | Origin Medsystems, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K955168 | SURGICAL CUTTER | Promex, Inc. | 1996-01-22 | Traditional | PDF ↗ |
Product code GEI · Class II · General, Plastic Surgery. Data: openFDA.